FDA Drug recall D-0511-2026
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, G…
- FDA Drug
- Class III
- ongoing
- Published 2026-05-13
On 2026-05-13 the FDA classified a Class III recall of busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, G… by Unichem Pharmaceuticals Usa, citing subpotent drug.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0511-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-04-13 |
| Published | 2026-05-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Unichem Pharmaceuticals Usa |
| Distribution | US |
Product
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.
Reason
Subpotent drug
Identifiers
| ndc | 29300-244-01 |
|---|---|
| ndc | 29300-244-05 |
| ndc | 29300-245-01 |
| ndc | 29300-245-05 |
| ndc | 29300-246-01 |
| ndc | 29300-246-18 |
| ndc | 29300-246-05 |
| ndc | 29300-246-16 |
| ndc | 29300-247-16 |
| ndc | 29300-247-01 |
| ndc | 29300-247-05 |
| ndc | 29300-477-16 |
| ndc | 29300-477-01 |
| ndc | 29300-477-18 |
| ndc | 29300-477-05 |
| ndc | 29300-478-16 |
| ndc | 29300-478-01 |
| ndc | 29300-478-05 |
| code_info | Lot: ZBUL25001, Exp 12/31/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0511-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.